Senior Quality Assurance Engineer
I’m working in partnership with a leading medical device manufacturer, they specialise in the design, development, and manufacture of products for the healthcare industry. They are now looking for a Senior Quality Assurance Engineer to join the Quality Assurance Team.
The role will involve ensuring that the site Quality Management System is maintained for product manufacturing, storage, and distribution processes. This will include prioritising departmental activities to meet the demands of the business.
• Ensuring that the site Quality Management System is maintained for product manufacturing, storage, and distribution processes
• General day-to-day quality assurance activities including, but not limited to, document control, change control, CAPA/NCR
• Provide Quality Assurance support to initiate, engage and escalate critical and major compliance issues through QMS processes, including deviations, CAPAs and change control
• Manage and monitor the KPIs for the business, identifying trend areas and communicate to key stakeholders to drive improvements
• Co-ordinate audits in preparing and participate in both internal and external audits with customers and regulatory authorities
• QA representative for Design Controls and Risk Management for new product development projects and device change initiatives
• Work with procurement on supplier quality standards, supplier quality agreements, metrics
• Minimum 3 years’ experience in Quality Assurance, working to the requirements for international quality systems for a medical device company, including ISO 13485 and 9001 required
• Experience of working in the medical device, or equivalent, industry
• Educated to degree level, or equivalent, in a Science or Engineering based discipline
• Lead Audit qualification
• Experience of working within Quality for an MDSAP QMS would be desirable